BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 617218 · Received August 3, 2004

    Report

    Report Number
    6000001-2004-01221
    Event Type
    Malfunction
    Date Received
    August 3, 2004
    Date of Event
    July 12, 2004
    Report Date
    July 12, 2004
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN OBF (OUT-OF-BOX FAILURE) WITH A FAILURE CODE 500. THE REPORTED ISSUE OCCURRED DURING BIOMED TESTING. THE HOSPITAL REPRESENTATIVE STATED THEY HAVE NO RECORD OF ANY PT INCIDENT INVOLVING THIS PUMP SINCE THE LAST BAXTER SERVICE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD COLLEAGUE 3CX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA